Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN15160 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Lower IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Mid IV Dose 1 | EXPERIMENTAL | Randomized 3:1 |
| Mid IV Dose 2 | EXPERIMENTAL | Randomized 3:1 |
| Higher IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Lower SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Mid SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Higher SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Name | Type | Description |
|---|---|---|
| REGN15160 (IV) | DRUG | Administered in single intravenous (IV) dose |
| Matching Placebo (IV) | DRUG | Administered in single IV dose |
| REGN15160 (SC) | DRUG | Administered in single subcutaneous (SC) dose |
| Matching Placebo (SC) | DRUG | Administered in single SC dose |
Key Inclusion Criteria: 1. Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards 2. Has received c...
REGN15160 is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. (REGN). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers in a completed trial related to COVID-19.
REGN15160 is being studied for use in healthy individuals as part of a clinical trial related to COVID-19. The Phase 1 trial assessed its safety and tolerability in adult healthy volunteers. It is not approved for any indication and remains in clinical development.
REGN15160 is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker REGN. Regeneron is conducting clinical research on this investigational small molecule in healthy volunteers.
REGN15160 is in Phase 1 clinical development. The single Phase 1 trial has been completed. The drug is investigational and has not been approved by regulatory authorities. It is being evaluated for safety and tolerability in healthy volunteers.
REGN15160 has one completed Phase 1 clinical trial, identified as NCT05293678. This trial was titled 'Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19' and enrolled 104 participants in Belgium.
REGN15160 is described as a small molecule, not a monoclonal antibody. The clinical trial title mentions Regeneron anti-SARS-CoV-2 monoclonal antibodies, but REGN15160 itself is classified as a small molecule modality in the development program.